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RX DIPHENHYDRAMINE HYDROCHLORIDE TABLETS 25MG 1.NAME OF THE MEDICINAL PRODUCT Diphenhydramine hydrochloride 25mg Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diphenhydramine tablets contains 25mg Diphenhydramine Hydrochloride per tablet. 3. PHARMACEUTICAL FORM Tablets to be taken orally. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications
seizure disorders, narrow-angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis and chronic obstructive pulmonary disease (COPD), moderate to severe hepatic impairment and moderate to severe renal impairment. Tolerance may develop with continuous use. Seek medical advice if sleeplessness persists, as insomnia may be a symptom of serious underlying medical illness. This medication should not be used continuously for more than 2 weeks without consulting a doctor. May increase the effects of alcohol, therefore alcohol should be avoided. Avoid use of other antihistamine-containing preparations, including topical antihistamines and cough and cold medicines. Use with caution in the elderly, who are more likely to experience adverse effects. Avoid use in elderly patients with confusion.
4.2 Posology and method of administration
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Oral administration only.
Keep out of the sight and reach of children.
Two tablets to be taken 20 minutes before going to bed, or as directed by a physician.
4.5 Interaction with other medicinal products and other forms of interaction
Do not exceed the stated dose or frequency of dosing.
Diphenhydramine may potentiate the sedative effects of alcohol and other CNS depressants (e.g. tranquillizers, hypnotics and anxiolytics).
An aid to the relief of temporary sleep disturbance.
Do not use in children under 16 years. This medication should not be used continuously for more than 2 weeks without consulting a doctor. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Diphenhydramine is contraindicated in those with the following conditions: stenosing peptic ulcer, pyloroduodenal obstruction.
Monoamine oxidase inhibitors(MAOI) prolong and intensify the anticholinergic effects of diphenhydramine. The product should be used with caution with MAOIs or within 2 weeks of stopping an MAOI.
4.4 Special Warnings and precautions for use
As diphenhydramine has some antimuscarinic activity, the effects of some anticholinergic drugs (e.g. atropine, tricyclic antidepressants) may be potentiated therefore medical advice should be sought before taking diphenhydramine with such medicines.
Diphenhydramine should be used with caution in patients with myasthenia gravis, epilepsy or
Diphenhydramine is an inhibitor of the cytochrome p450 isoenzyme CYP2D6.
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Therefore, there may be a potential for interaction with drugs which are primarily metabolised by CYP2D6, such as metoprolol and venlafaxine.
uncommon (occurring in > 1/1,000 to <1/100) or rare (occurring in < 1/1,000). Body System
Undesirable effect
Frequency
Diphenhydramine should not be used in patients receiving any of the above drugs unless directed by a doctor.
General disorders and administration site conditions
fatigue
Common
4.6 Fertility, Pregnancy and lactation
Immune system disorders
Hypersensitivity reactions including rash, urticaria, dyspnoea and angioedema
Unknown
Psychiatric disorders*
confusion, Unknown paradoxical excitation (e.g. increased energy, restlessness, nervousness)
Nervous system disorders
sedation, drowsiness, disturbance in attention, unsteadiness, dizziness, convulsions, headache, paraesthesia, dyskinesias
Common
Eye disorders
blurred vision
Unknown
Cardiac disorders
tachycardia, palpitations
Unknown
Respiratory, thoracic and mediastinal disorders
thickening of bronchial secretions
Unknown
Gastrointestinal disorders
dry mouth Common gastrointestinal Unknown disturbance including nausea, vomiting
Musculoskeletal and connective tissue disorders
muscle twitching
Pregnancy Diphenhydramine crosses the placenta. Because animal reproduction studies are not always predictive of human response and since there is inadequate experience with use of diphenhydramine in pregnant women, the potential risk for humans is unknown. Use of sedating antihistamines during the third trimester may result in reactions in the newborn or premature neonates. This drug is not recommended during pregnancy. Consult a doctor before use. Lactation Diphenhydramine has been detected in breast milk, but the effect of this on breastfed infants is unknown. Diphenhydramine is not recommended for use during lactation. Consult a doctor before use. 4.7 Effects on ability to drive and use machines Diphenhydramine is a hypnotic and will produce drowsiness or sedation soon after the dose has been taken. It may also cause dizziness, blurred vision, cognitive and psychomotor impairment. These can seriously affect the patient's ability to drive and use machines. If affected, do not drive or operate machinery. 4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). Adverse reactions which have been observed in clinical trials and which are considered to be common (occurring in > 1/100 to < 1/10) or very common (occurring in > 1/10) are listed below by MedDRA System Organ Class. The frequency of other adverse reactions identified during post- marketing use is unknown, but these reactions are likely to be
Unknown
Unknown
urinary difficulty, Unknown Renal and urinary disorders urinary retention
* The elderly are more prone to confusion and paradoxical excitation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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4.9 Overdose Overdose is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include mydriasis, fever, flushing, agitation, tremor, dystonic reactions, hallucinations and ECG changes. Large overdose may cause rhabdomyolysis, convulsions, delirium, toxic psychosis, arrhythmias, coma and cardiovascular collapse. Treatment should be supportive and directed towards specific symptoms. Convulsions and marked CNS stimulation should be treated with parenteral diazepam.
Diphenylmetoxyacetic acid and is also dealkylated. The metabolites are conjugated with glycine and glutamine and excreted in urine. Only about 1% of a single dose is excreted unchanged in urine. Elimination The elimination half-life ranges from 2.4-9.3 hours in healthy adults. The terminal elimination half-life is prolonged in liver cirrhosis. 5.3 Preclinical safety data None stated.
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
5.1 Pharmacodynamic properties Diphenhydramine is an ethanolamine-derivative antihistamine. It is an antihistamine with anticholinergic and marked sedative effects. It acts by inhibiting the effects on H1-receptors.
6.1 List of excipients Anhydrous lactose
Diphenhydramine is effective in reducing sleep onset (ie, time to fall asleep) and increasing the depth and quality of sleep.
Silicon dioxide
5.2 Pharmacokinetic properties
6.2 Incompatibilities Not applicable.
Absorption Diphenhydramine hydrochloride is rapidly absorbed following oral administration. Apparently it undergoes first-pass metabolism in the liver and only about 40-60% of an oral dose reaches systematic circulation as unchanged Diphenhydramine. Distribution
Stearic acid, powder Microcrystalline cellulose
Maize starch
6.3 Shelf life Diphenhydramine has a shelf-life of 4 years in HDPE bottles and 3 years in blister packs. 6.4 Special precautions for storage Store in a dry place. 6.5 Nature and contents of container
It is rapidly distributed throughout the whole body. Peak plasma concentrations are attained within 1-4 hours. The sedative effect also appears to be maximal within 1-3 hours after administration of a single dose.
High density polyethylene bottles with a polypropylene closure and cotton wool wadding, or an aclar/polyethylene/PVC or PVC/PVDC strip with a heat sealable aluminium foil. Bottles of 16 or 20 tablets and strips of 4, 8, 16, 20 or 24 tablets.
It is positively correlated with the plasma drug concentration.
6.6 Special precautions for disposal and other handling
Biotransformation
Not applicable.
Diphenhydramine is approx 80-85% bound to plasma proteins. Diphenhydramine is rapidly and almost completely metabolised. The drug is metabolised principally to
7. MANUFACTURER:
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Manufactured in India by: TAJ PHARMACEUTICALS LTD. Mumbai, India At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad 438225, Gujarat, INDIA